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U.S. Department of Health and Human Services

Class 2 Device Recall 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm

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  Class 2 Device Recall 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm see related information
Date Initiated by Firm May 19, 2021
Create Date July 01, 2021
Recall Status1 Terminated 3 on March 31, 2023
Recall Number Z-1994-2021
Recall Event ID 88057
Product Classification Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
Product 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire

Unit Label:
PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire
Code Information Catalog (REF) Number: CK000340B UDI Code: (01)00801741126697 Lot Number: 20BBK658
Recalling Firm/
Manufacturer		 Bard Access Systems Inc.
605 N 5600 W
Salt Lake City UT 84116-3738
For Additional Information Contact
844-823-5433
Manufacturer Reason
for Recall		 Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.
FDA Determined
Cause 2		 Process control
Action On 05/19/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE CORRECTION" Notification via FedEx 2-day to customers informing them that the Recalling Firm has confirmed through customer complaint that a number of catheter convenience kits labeled as having 70cm guidewires may actually contain 50cm guidewires. The Recalling Firm is providing customers with a quick way of identifying if their kit contains the correct or incorrect size guidewire by determining the number of loops of the wire. Customers are instructed to: 1. Immediately review their inventory for the specific Catalog (Ref) and lot numbers listed. Determine if the product has the correct product based on the number of loops of the guidewire while the product is still in the packaging material. Product may be discarded when clinically necessary and replacement requested. 2. Share this recall notification with all users within or outside their facility network to which they may have further distributed the affected products to ensure these additional users are also aware of this advisory notice. 3. Complete the attached Customer Response Form and return to the Recalling Firm contact noted on the form whether or not they have any of the impacted material so that Recalling Firm may acknowledge receipt of this notification per FDA requirements and subsequently process the product replacement, if necessary. For further assistance or for questions - contact: North American Regional Complaint Center 1-84BD-LIFE (1-844-823-5433) Say Recall when prompted MonFri 8:00am and 5:00pm CT
Quantity in Commerce 30 kits
Distribution U.S. Nationwide distribution in the state of RI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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